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GTx Announces Top-Line Results from Placebo-Controlled ASTRID Trial of Enobosarm in Women with Stress Urinary Incontinence
“We are very disappointed that the ASTRID Trial did not achieve its
primary endpoint,” said
About the ASTRID Trial
The ASTRID (Assessing Enobosarm for Stress Urinary Incontinence Disorder) Trial is a double-blind, placebo-controlled, parallel design, Phase 2 study to assess clinical activity and safety of enobosarm (GTx-024) in postmenopausal women with Stress Urinary Incontinence (SUI). The trial enrolled 493 women and was conducted at over 60 clinical trial centers across the United States. To learn more about the ASTRID clinical trial, click here.
About Stress Urinary Incontinence
Stress urinary incontinence (SUI) refers to the unintentional leakage of urine during activities that increase abdominal pressure such as coughing, sneezing or physical exercise. SUI, the most common type of incontinence suffered by women, affects up to 35 percent of adult women. There are a variety of treatments that are used to treat SUI in women, such as behavioral modification and pelvic floor physical therapy, especially as initial treatment options. As the condition worsens however, bulking agents and surgical procedures are often the most widely used treatments.
About Enobosarm and SUI
Enobosarm (GTx-024), a selective androgen receptor modulator (SARM), has been evaluated in 27 completed or ongoing clinical trials enrolling over 2,200 subjects, in which approximately 1,500 subjects were treated with enobosarm at doses ranging from 0.1 mg to 100 mg. At all evaluated dose levels, enobosarm was observed to be generally safe and well tolerated. The rationale for evaluating enobosarm as a treatment for SUI is supported by preclinical in vivo data demonstrating increases in pelvic floor muscle mass following treatment with GTx’s SARM compounds, including enobosarm, and the proof-of-concept Phase 2 clinical trial of enobosarm 3 mg for the treatment of postmenopausal women with SUI.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon
GTx’s current expectations. Forward-looking statements involve risks and
uncertainties, and include, but are not limited to, statements relating
to GTx’s ongoing clinical development of its selective androgen receptor
degrader (SARD) compounds. GTx’s actual results and the timing of events
could differ materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which include,
without limitation, the risks (i) that additional clinical development
of GTx’s SARD compounds for the treatment of castration-resistant
prostate cancer (CRPC) will be required beyond the ongoing study; and
(ii) any future development of SARDs in CRPC is contingent on obtaining
sufficient additional capital to permit such development, which it may
be unable to do. GTx will continue to need additional funding and may be
unable to raise capital when needed, which would force GTx to delay,
reduce or eliminate its product candidate development programs and
potentially cease operations. GTx’s actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and uncertainties.
You should not place undue reliance on these forward-looking statements,
which apply only as of the date of this press release. GTx’s quarterly
report on Form 10-Q for the period ended